Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation (GREFFE)

October 7, 2019 updated by: Laurent BRONDEL, University of Burgundy
This study evaluates the influence of the taste sensitivity, of food preferences and of the reward system on the energetic balance before and after liver transplantation in cirrhotic patients and after kidney transplantation in renal failure patients

Study Overview

Status

Unknown

Conditions

Detailed Description

Background and Aims: Protein-energy malnutrition is associated to cirrhosis with a high prevalence and greatly increases the morbidity and mortality of the disease. Malnutrition results of numerous causes including intestinal malabsorption, increased energy resting expenditure, metabolism disturbances, impaired sensory taste and changes in food preferences which might participate to a reduction in food intake. The aim of this study was to determine the relationships that may exist between taste sensitivity and food preferences on the one hand, eating habits, nutritional status, energy balance and biological parameters including amino acids on the other hand in patients with end-stage cirrhosis and in patients with renal failure.

Fifteen end-stage cirrhotic patients and 15 renal failure patients will be included and matched with 30 healthy subjects. The following parameters will be evaluated during a morning testing session: gustatory sensitivity using a triangular detection threshold method for sweet, salty and umami solutions; preferences for fat- and carbohydrate-rich foods using the PrefQuest score; liking for six foods (protein-, carbohydrate- and fat-rich foods) and wanting for 18 foods (photographs); hunger sensation; energy intake (24 h ingested food); body composition (BMI and impedancemetry); resting energy expenditure (indirect calorimetry) and physical activity (questionnaire). Several plasmatic parameters (amino-acids, leptin, ghrelin, lipid profile) will be also determined.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Burgundy
      • Dijon, Burgundy, France, 21000
        • Recruiting
        • Center for Taste and Feeding Behaviour
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 15 patients waiting for renal transplantation
  • 15 patients waiting for liver transplantation
  • 30 healthy subjects matched for gender, age and body mass index

Description

Inclusion Criteria:

  • written consent
  • patients in waiting renal transplant
  • patients in waiting liver transplant

Exclusion Criteria:

  • chronic infection
  • acute infection
  • cancer
  • antibiotic treatments
  • alcool abuse
  • pregnant woman
  • specific or restrictive diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cirrhotic subjects
15 cirrhotic patients in end-stage in waiting a graft
Chronic kidney disease subjects
15 chronic kidney disease patients in end-stage in waiting a graft
Healthy subjects
30 healthy subjects to compare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy expenditure
Time Frame: two years
evice: indirect calorimetry (sensormedics)
two years
body composition
Time Frame: 2 years
Device: Multifrequency bio-impedancemetry (aminostats)
2 years
amino acids profil in plasma
Time Frame: 2 years
Biological measurments
2 years
Food preferences
Time Frame: 2 years
Device: Treshold taste detection
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Burgundy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00254-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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